Biospecimen Senior Specialist (Clinical Sample Acquisition)
About The Position
At Roche, we foster a culture where individuality is embraced, and diverse qualities are valued. Our aim is to prevent, stop, and cure diseases, ensuring universal access to healthcare. The Biospecimen Senior Specialist (Clinical Sample Acquisition) will support the Pleasanton Biospecimen Acquisition and Management (BAM) subchapter, which is part of the Development Services and Integration (DSI) chapter within Roche Diagnostics Solutions’ R&D organization. BAM is a global service function responsible for the acquisition, characterization, and management of biological materials. In this role, you will report to the BAM Acquisition Team Lead and oversee clinical biospecimen and data requests across various projects. You will manage the entire acquisition lifecycle, ensuring timely delivery to stakeholders. Collaboration with local and global partners will be key to aligning sample requirements with internal processes and industry standards. This role also involves managing the end-to-end data integrity of acquired biospecimens, including quality checks, data imports, and inventory exports, while adhering to strict data privacy, GCP, GLP, and regulatory compliance standards to maintain patient trust. This position is based in Pleasanton, CA, requiring approximately 3 days per week on-site.
Requirements
- Bachelor's degree in a scientific discipline.
- 3 years of experience applying broad knowledge in molecular biology or clinical studies.
- Understanding of medical device development (especially assays) or experience in the technical and ethical aspects of biospecimen utilization, clinical operations, or sample management.
- Experience in clinical data management, clinical research, clinical trial operations, or biospecimen management.
- Demonstrated success being part of a high-performing team environment, thinking strategically, and excelling in cross-functional collaboration.
- Commitment to developing skills to better oneself and the team.
Nice To Haves
- Advanced degree in a scientific discipline.
- Prior experience navigating a highly complex, global environment to align cross-functional stakeholders.
- Experience in SQL, Python, and R.
- Skills to transform fragmented vendor-provided datasets into a standardized data manifest, ensuring ethical and legal compliance of all samples used by Roche.
Responsibilities
- Drive the full lifecycle of sample acquisition and data management to ensure customer requests are fulfilled accurately and on time.
- Manage information within LIMS frameworks, maintaining rigorous documentation standards and data quality in accordance with validated GxP regulations.
- Partner with R&D, Legal, and Logistics teams to align project requirements, manage global stakeholders, and represent the focus area in high-level meetings.
- Serve as a Subject Matter Expert (SME) to guide decision-making, manage complex requests autonomously, and influence project strategy through scientific expertise.
- Proactively identify and escalate project risks while adapting to shifting priorities to meet strict deadlines and quality standards.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Benefits detailed at the link provided below.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
5,001-10,000 employees
